What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL04425/0623 .

Suprax Tablets 200mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Suprax 200mg Tablets

Cefixime

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Suprax is and what it is used for
2. What you need to know before you take Suprax
3. How to take Suprax
4. Possible side effects
5. How to store Suprax
6. Contents of the pack and other information

1. What Suprax is and what it is used for

Suprax 200mg Tablets (called Suprax in this leaflet) contains a medicine called cefixime. This belongs to a group of antibiotics called ‘cephalosporins’.

Suprax is used to treat infections caused by bacteria.

These include infections of the:

  • Ear
  • Nose, sinuses (such as sinusitis)
  • Throat (such as tonsillitis, pharyngitis)
  • Chest and lungs (such as bronchitis, pneumonia)
  • Urinary system (such as cystitis and kidney infections)

2. What you need to know before you take Suprax

Do not take Suprax:

  • if you are allergic to cefixime, any other cephalosporin antibiotics including penicillin or to any of the other ingredients of this medicine (listed in section 6).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.

Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Suprax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Suprax:

  • if you have ever had colitis
  • if you have kidney problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Suprax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Suprax can affect the way some other medicines work. Also some medicines can affect the way Suprax works.

In particular, tell your doctor if you are taking the following:

  • Medicines to thin the blood such as warfarin

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine can cause symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. If you experience any of these effects don’t drive or use machinery.

Medical Tests

If you require any tests (such as blood or urine tests) while taking this medicine, please make sure your doctor knows that you are taking Suprax.

3. How to take Suprax

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

  • Take this medicine by mouth
  • Swallow tablets whole with a drink of water
  • If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

Carefully read the label from the pharmacist. Ask your pharmacist if you are not sure about the dose to take. The medicine should be taken for the prescribed number of days.

The recommended dose is:

Adults, Elderly and Children over 10 years or weighing more than 50kg

  • 1-2 tablets each day given as a single or divided dose

People with kidney problems

  • Your doctor may prescribe a lower dose

Children under 10 years old

  • Suprax should not be given to children under 10 years old

If you take more Suprax than you should

If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Suprax

If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Suprax

Do not stop taking this medicine without talking to your doctor. You should not stop taking Suprax just because you feel better. This is because the infection may come back or get worse again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away or go to the nearest hospital casualty department if you notice any of the following serious side effects – you may need urgent medical treatment:

  • You have an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson’ syndrome.
  • Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’
  • You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’
  • You get infections more easily than usual. This could be because of a blood disorder. This normally gets better after stopping the medicine
  • You bruise or bleed more easily than normal. This could be because of a blood disorder. This normally gets better after stopping the medicine
  • If your child gets nose bleeds, bleeding gums, chills, tiredness, pale skin (often with a yellow tinge), shortness of breath. This may be due to haemolytic anaemia.
  • Changes in the way the kidneys are working or blood in your child’s urine
  • Fits (convulsions) - Frequency not known
  • A brain condition with symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. This may be something called encephalopathy. This side effect is more likely if you have taken an overdose or you already have a problem with your kidneys

Stop taking this medicine and contact your doctor without delay if you get:

  • Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called ‘Pseudomembranous colitis’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Feeling sick (nausea) or being sick (vomiting)
  • Stomach pains, indigestion or wind
  • Headaches
  • Feeling dizzy
  • Feeling itchy in the genital or vaginal area

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

Blood tests

Suprax can cause blood clots or small changes to the way the liver and kidney work. This would be shown up in blood tests. This is not common and goes back to normal after stopping this medicine.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Suprax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and blister pack after EXP:.

Store below 25°C.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Suprax 200mg Tablets contain

  • Each tablet contains 200mg of the active substance, cefixime.
  • The other ingredients are microcrystalline cellulose, pregelatinised starch, calcium hydrogen phosphate dihydrate, magnesium stearate, hypromellose, macrogol 6000 and titanium dioxide (E171).

What Suprax 200mg Tablets look like and content of the pack

Suprax is available as an off-white, convex, film coated tablet engraved with ‘ORO’ on one side.

Suprax is available in blister packs containing 1, 2, 7 or 14 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: [email protected] .com

Manufacturer

S.C. Zentiva, S.A.
50 Theodor Pallady Blvd.
District 3
Bucharest
032266
Romania

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in May 2018

© Sanofi, 1998-2018

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